Healthy ParticipantsPhase 1NCT07643272
A Study on the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of HMPL-760 Capsules
A Phase 1 study testing HMPL-760 and Rabeprazole and HMPL-760 in people with Healthy Participants, run by Hutchmed at 1 site in China.
Trial summary
This is a single-center, open-label, randomized, four-period, six-sequence study with a planned enrollment of 24 healthy participants. The study consists of a screening period, a dosing period (Cycles 1, 2, 3, and 4), and a follow-up period. Screening must occur within 14 days prior to the first dose of study drug. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- HMPL-760 and Rabeprazole and HMPL-760
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 31 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants are fully aware of this study and voluntarily sign the ICF.
- Male or female aged 18 to 45 years old (inclusive).
- Participant's body mass index (BMI) at screening: 18 kg/m2 < BMI ≤ 29.9 kg/m2 and weight ≥ 50 kg for males and ≥ 45 kg for females.
- Participant is willing and able to comply with the protocol in all aspects.
Who cannot join
- Known history of any gastrointestinal surgery or any condition that could affect drug absorption (e.g., cholecystectomy, achlorhydria, peptic ulcer disease, gastric/intestinal surgery or history of resection; prior appendectomy or hernia repair is allowed).
- Clinically significant disease within 8 weeks prior to the first dose or clinically significant infection within 4 weeks prior to the first dose.
- Clinically significant abnormal findings in physical examination, vital signs, or laboratory tests at screening.
- Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at screening.
- Participants who smoked over 10 cigarettes daily within 3 months before screening.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031
About this study
Official title: An Open-Label, Randomized, Four-Period, Six-Sequence Phase I Study to Evaluate the Effect of Food and Proton Pump Inhibitor Rabeprazole on the Pharmacokinetics of HMPL-760 Capsules in Healthy Participants
This is a single-center, open-label, randomized, four-period, six-sequence study with a planned enrollment of 24 healthy participants. The study consists of a screening period, a dosing period (Cycles 1, 2, 3, and 4), and a follow-up period. Screening must occur within 14 days prior to the first dose of study drug. Enrolled participants will be randomly assigned to one of 6 dosing sequences in the ratio of 1:1:1:1:1:1 to complete Cycles 1-3 dosing to evaluate the effect of different types of food on the PK of HMPL-760, and then to receive rabeprazole and HMPL-760 in Cycle 4 to assess the effect of PPI on the PK of HMPL-760 (see dosing sequence table for details).
- Conditions
- Healthy Participants
- Being tested
- HMPL-760, Rabeprazole and HMPL-760
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-760Drug
300 mg HMPL-760 will be administered orally once daily on Day 1, Day 6 and Day 11.
Rabeprazole and HMPL-760Drug
20 mg of rabeprazole will be administered orally once daily in the morning from Day 15 to Day 21, and a 300 mg oral dose of HMPL-760 will be administered concomitantly with rabeprazole on Day21.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A- HMPL-760 | Experimental | All participants in treatment A will fast overnight for at least 10 hours prior to HMPL-760 dosing. Receives: Drug: HMPL-760 |
| Treatment B- HMPL-760 | Experimental | All participants in treatment B will receive a standardized high-fat meal approximately 30 minutes before HMPL-760 administration Receives: Drug: HMPL-760 |
| Treatment C- HMPL-760 | Experimental | All participants in treatment C will receive a standardized low-fat meal approximately 30 minutes before HMPL-760 administration Receives: Drug: HMPL-760 |
| Treatment D- Rabeprazole and HMPL-760 | Experimental | All participants receive rabeprazole 20 mg orally QD(Quaque Die) 1 h before the breakfast on Day 15 and the morning of Day 16 to Day 20. Rabeprazole and HMPL-760 are orally administered concomitantly under fasted conditions on the morning of Day 21. Receives: Drug: Rabeprazole and HMPL-760 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-last
Area under the plasma concentration-time curve from time zero to the last time point t where the concentration could be accurately determined
Measured: Day 1 to Day 25
AUC 0-inf
Area under the plasma concentration-time curve from time 0 to infinity
Measured: Day 1 to Day 25
Cmax
Maximum plasma concentration
Measured: Day 1 to Day 25
Secondary outcomes (5)
Tmax
Time to Cmax
Measured: Day 1 to Day 25
tlag
Lag Time
Measured: Day 1 to Day 25
t1/2
Terminal elimination half-life
Measured: Day 1 to Day 25
Adverse events rate
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Measured: Day 1 to Day 32(±1 day)
Laboratory tests
Number of participants with abnormal laboratory tests results
Measured: Day 1 to Day 32(±1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start30 Jun 2026
- Primary completion31 Jul 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by HutchmedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643272
- Sponsor's protocol ID
- 2026-760-00CH1
- Status last verified
- Sep 2026
- First submitted
- 8 Jun 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Four-Period, Six-Sequence Phase I Study to Evaluate the Effect of Food and Proton Pump Inhibitor Rabeprazole on the Pharmacokinetics of HMPL-760 Capsules in Healthy Participants
- ClinicalTrials.gov ID
- NCT07643272
- Acronym / sponsor ID
- 2026-760-00CH1
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, open-label, randomized, four-period, six-sequence study with a planned enrollment of 24 healthy participants. The study consists of a screening period, a dosing period (Cycles 1, 2, 3, and 4), and a follow-up period. Screening must occur within 14 days prior to the first dose of study drug. Enrolled participants will be randomly assigned to one of 6 dosing sequences in the ratio of 1:1:1:1:1:1 to complete Cycles 1-3 dosing to evaluate the effect of different types of food on the PK of HMPL-760, and then to receive rabeprazole and HMPL-760 in Cycle 4 to assess the effect of PPI on the PK of HMPL-760 (see dosing sequence table for details).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A- HMPL-760 | Experimental | Drug: HMPL-760All participants in treatment A will fast overnight for at least 10 hours prior to HMPL-760 dosing. |
| Treatment B- HMPL-760 | Experimental | Drug: HMPL-760All participants in treatment B will receive a standardized high-fat meal approximately 30 minutes before HMPL-760 administration |
| Treatment C- HMPL-760 | Experimental | Drug: HMPL-760All participants in treatment C will receive a standardized low-fat meal approximately 30 minutes before HMPL-760 administration |
| Treatment D- Rabeprazole and HMPL-760 | Experimental | Drug: Rabeprazole and HMPL-760All participants receive rabeprazole 20 mg orally QD(Quaque Die) 1 h before the breakfast on Day 15 and the morning of Day 16 to Day 20. Rabeprazole and HMPL-760 are orally administered concomitantly under fasted conditions on the morning of Day 21. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants are fully aware of this study and voluntarily sign the ICF.
- Male or female aged 18 to 45 years old (inclusive).
- Participant's body mass index (BMI) at screening: 18 kg/m2 < BMI ≤ 29.9 kg/m2 and weight ≥ 50 kg for males and ≥ 45 kg for females.
- Participant is willing and able to comply with the protocol in all aspects.
Key exclusion criteria (5 listed)
- Known history of any gastrointestinal surgery or any condition that could affect drug absorption (e.g., cholecystectomy, achlorhydria, peptic ulcer disease, gastric/intestinal surgery or history of resection; prior appendectomy or hernia repair is allowed).
- Clinically significant disease within 8 weeks prior to the first dose or clinically significant infection within 4 weeks prior to the first dose.
- Clinically significant abnormal findings in physical examination, vital signs, or laboratory tests at screening.
- Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at screening.
- Participants who smoked over 10 cigarettes daily within 3 months before screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMPL-760300 mg HMPL-760 will be administered orally once daily on Day 1, Day 6 and Day 11. | Drug | Treatment A- HMPL-760, Treatment B- HMPL-760, Treatment C- HMPL-760 |
| Rabeprazole and HMPL-76020 mg of rabeprazole will be administered orally once daily in the morning from Day 15 to Day 21, and a 300 mg oral dose of HMPL-760 will be administered concomitantly with rabeprazole on Day21. | Drug | Treatment D- Rabeprazole and HMPL-760 |
Primary outcome
AUC 0-last
Time frame: Day 1 to Day 25
Area under the plasma concentration-time curve from time zero to the last time point t where the concentration could be accurately determined
AUC 0-inf
Time frame: Day 1 to Day 25
Area under the plasma concentration-time curve from time 0 to infinity
Cmax
Time frame: Day 1 to Day 25
Maximum plasma concentration
5 secondary outcomes
Tmax
Time frame: Day 1 to Day 25
tlag
Time frame: Day 1 to Day 25
t1/2
Time frame: Day 1 to Day 25
Adverse events rate
Time frame: Day 1 to Day 32(±1 day)
Laboratory tests
Time frame: Day 1 to Day 32(±1 day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HMPL-760 and Rabeprazole and HMPL-760 in people with Healthy Participants, run by Hutchmed at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC 0-last (time frame: Day 1 to Day 25). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.